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The Televere Digital Dental Imaging System is intended for radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. Not for mammography. Not for fluorosopy.

The Televere Digital Dental Imaging System is an extraoral digital x-ray system comprised of two previously cleared individual components: (1) an intraoral detector component (K162619) which connects to a PC via a USB port and (2) and image management software package (i.e., Tigerview Professional, K061035). The device detector comes in two sizes: 600mm² (Hamamatsu CMOS area image sensor, S11684-12) and 884mm² (Hamamatsu CMOS area image sensor, S116845-12). X-ray generators that can integrate with the Televere Digital Dental Imaging System are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15mA inclusive, and with a tube voltage between 50 and 100kV inclusive, with built in controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time. The device and software cannot act as an x-ray generator controller. All control of xray generation is done by controls built into the generator itself. There is no connection between the device and the x-ray generator. The device is an x-ray receiver and does not control the generator.

The Televere Podiatry X-Ray System HF is intended for use by qualified clinicians for the x-ray of hands and feet. Not for mammography. Not fluoroscopy.

The Televere Podiatry X-Ray System HF consists of a combination of previously cleared Tigerview digital imaging software (K061035), a high frequency X-Ray generator (X-CEL MODEL HF 718BD, K160857), a PC-based computer and a power supply. Tigerview software provides an exposure control upgrade of the previously cleared HF x-ray generator by replacing the manual touchscreen of the Predicate Device (K160857) with the Tigerview computer software interface. Tigerview software provides basic image adjustment features as well as x-ray exposure control settings. An image adjustment system allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Tigerview software runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card.

The Televere Podiatry Digital Imaging System is intended for digital image capture use in podiatry radiographic examinations, wherever conventional screen-film systems may be used. Not for mammography. Not for fluoroscopy.

The Televere Podiatry Digital Imaging System consists of a combination of digital imaging software, a flat panel display (FPD), a PC-based computer, and a power supply. The PC based computer, x-ray generator and the power-supply are necessary for a the subject device. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional) and is being used unchanged in the subject device. This previously cleared software provides basic image adjustment features - an image management system allowing the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. The FPD component seeking clearance (VarexPaxScan2530C) has not been previously cleared by FDA as an individual component. The FPD uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide (GadOx) scintillator for displaying high quality images over a wide range of dose settings and is intended to be integrated into a complete X-ray system. This premarket notification seeks clearance for a combination finished device consisting of the combination of the previously cleared digital imaging software and the FPD component. The combination of the digital imaging software and the FPD does not affect the safety or efficacy of either component device alone, or in combination. A gigabit Ethernet port allows for tethered, non-wireless data transmission.

The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, pelvis, and extremities. Not for mammography.

The Televere Digital Imaging System consists of a combination of digital imaging software, a flat panel display (FPD), a PC-based computer and a power supply. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional). This previously cleared software provides basic image adjustment features: An image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PCcompatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. The FPD component seeking clearance (PerkinElmer Model XRPad 4343F N) has not been previously cleared by FDA. The FPD uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide (GadOx) scintillator for displaying high quality images over a wide range of dose settings and is intended to be integrated into a complete X-ray system. This premarket notification seeks clearance for a combination finished device consisting of the combination of the previously cleared digital imaging software and the FPD. The combination of the digital imaging software and the FPD does not affect the safety or efficacy of either component device alone, or in combination.

Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.

Visix Imaging is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Visix Imaging runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a USB port, parallel port, S-video port on a video capture card, or SCSI card.

TigerView Professional is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data. It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

TigerView Professional is an image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card.